A Study of Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area

NCT00913757 | Completed

• 2 other identifiers: 99990914909-C-N149
• Study Type: observational
• Target: 1,871
• Locations: 1 country
• Sites: 2

Brief Summary

Background:

• Liver cancer is the third most deadly and fifth most common cancer worldwide. Hepatocellular carcinoma (HCC) is the most frequent primary liver cancer, and it has grown more prevalent in the United States.
• More information is needed about the causes and effects of liver cancer, and further research into individuals who are at high risk for developing liver cancer is needed for early diagnosis and prevention. Objectives:
• To identify genetic factors that may help to explain the aggressiveness of liver cancer.
• To determine if HCC biomarkers exist in blood, urine, and tissue samples. Eligibility:
• Patients between the ages of 18 and 90 who have been diagnosed with HCC or have a high risk for developing HCC because of fatty liver disease (alcohol-related or non-alcohol-related) or chronic hepatitis B or C.
• Participants will reside in Baltimore City and the surrounding areas. Design:
• Participants will complete a questionnaire and provide blood and urine samples for testing:
• The questionnaire will include questions about individual and family medical history, tobacco use, and exposure to known factors for liver cancer.
• Blood and urine samples will be collected from all participants after the questionnaire.
• Tumor tissue and healthy tissue will be collected from selected participants if they undergo surgery for their cancer or disease.
• No specific treatment will be offered as part of this protocol, but participants have the option to be treated under different protocols.

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis, Alcoholic; Hepatitis, Alcoholic; Hepatitis, Chronic; Hepatitis, Viral, Human

Keywords

Hepatocellular Carcinoma; Liver Cancer; Chronic Liver Disease; Genome Wide Association Study; Gene Expression Profiling

Outcome Measures

Primary Outcomes (1)

• Large-scale molecular profiling study to identify HCC biomarkers for early diagnosis and prevention.

  Identification of HCC biomarkers for early diagnosis and prevention.

  ongoing

Study Arms (3)

Group 1

400 patients with primary HCC (Hepatocellular carcinoma)

Group 2

800 patients with chronic liver disease (high risk non-cancer cases)

Group 3

800 population-based controls, identified through a OMV database that will match cases by age, gender, race, and county of residency

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include 400 primary HCC cases, 800 patients with chronic liver disease (high risk non-cancer cases) and a sample of 800 population-based controls. The HCC and high risk non-cancer cases will be recruited at two Baltimore hospitals, the Veterans Affairs Medical Center and the University of Maryland School of Medicine over a period of 13 - 15 years. Controls will be identified through a Department of Motor Vehicle database and match cases by age, gender, race and county of residency.

You may qualify if:

• SELECTION OF CASE SUBJECTS (HCC AND HIGH RISK NON-CANCER CASES)
• We will recruit incident cases of pathologically confirmed primary liver cancer or risk factors for liver cancer (patients with chronic liver disease due to hepatitis B and/or C viral infection, nonalcoholic steatohepatitis or alcoholic cirrhosis) at all stages of the disease that are age greater than or equal to 18 years or less than or equal to 90 years. Treatment can be surgery or therapy. The following check list will be used to verify eligibility of a case subject.
• ELIGIBILITY CRITERIA- HCC CANCER CASES
• Diagnosed with primary liver cancer (HCC) within the last two years
• Physician diagnosis based on AFP and ultrasound/imaging or Pathological diagnosis of primary liver cancer made at the local hospital pathology department
• Resides in Maryland or surrounding states
• Has a residential working phone within his/her home (\*The reason for a participant having a residential working phone is that the matching population controls are selected through the Department of Motor Vehicles records and must have a residential telephone number to be selected as part of the random sample.)
• Age is greater than or equal to 18 years and less than or equal to 90 years
• A non-objection statement by the physician from the hospital where the patient was identified, or listed as the treating physician by the tumor registry or surgical pathology report, to contact the patient is obtained
• Is not currently residing in an institution, such as a prison, nursing home, or shelter
• Is not a severely ill patient in the intensive care unit
• Is able to give informed consent
• Is physically and mentally capable of performing the interview
• Must understand English well enough to be interviewed
• Has never been interviewed as a control for this study

You may not qualify if:

• Liver cancer patients who are older than 90 years are excluded because of co-morbidity considerations and the difficulty of matching those cases with population-based controls.
• Children and institutionalized patients are excluded from the proposed study. Very few HCC patients at the 3 participating hospitals are younger than 18 years of age and HCC incidence mainly occurs in adults.
• High Risk Non-Cancer patients who are older than 90 years are excluded because of co-morbidity considerations and the difficulty of matching those cases with population-based controls.
• Children and institutionalized patients are excluded from the proposed study. Very few HCC patients at the 3 participating hospitals are younger than 18 years of age and HCC incidence mainly occurs in adults. High-Risk Non-Cancer cases who are younger than 18 years are excluded due to the need of matching with HCC cases and population controls.
• Population based controls who are older than 90 years are excluded because of co-morbidity considerations and the difficulty of matching with HCC cases and high risk non-cancer cases.
• Population controls who are younger than 18 years or are institutionalized are excluded due to the need of matching with HCC cases and high-risk non-cancer cases.
• Population controls with prior cancer with the exception of non-melanomic skin cancer (squamous or basal cell).

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

University of Maryland Medical Center

Baltimore, Maryland, United States

Location

Veterans Affairs Medical Center

Baltimore, Maryland, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue samples, mouth wash and urine.

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis, Alcoholic; Hepatitis, Alcoholic; Hepatitis, Chronic; Hepatitis, Viral, Human; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Liver Diseases, Alcoholic; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Hepatitis; Chronic Disease; Disease Attributes; Virus Diseases; Infections

Study Officials

• Xin Wang, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 4, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 4, 2020

Record last verified: 2020-05

Locations

US (2)